OverweightNCT03652532
Alternate Day Fasting and Exercise in Overweight or Obese Adults
A study testing Alternate Day Fasting and Exercise in people with Overweight and Obesity, run by Gangnam Severance Hospital.
Trial summary
Alternate day fasting is known to be helpful to control weight and have a positive effect on insulin resistance and cardiovascular risk factors. However, there have been no studies on weight reduction program combining alternate day fasting with exercise which preserves lean mass in Korea. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Overweight, Obesity, Diet Modification
- What is being tested?
- Alternate Day Fasting and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2014to 8 Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20-65 years
- Body mass index (BMI) more than 23.0 kg/m² (overweight or obese for Asian populations, according to the World Health Organization)
Who cannot join
- Participants with weight gain more than 5kg in the last 3 months
- Participants with history of bariatric surgery
- Participants with secondary obesity, such as hypothyroidism
- Participants with uncontrolled hypertension or type 1 diabetes
- Participants who are taking anti-diabetic medications due to type 2 diabetes
- Participants with hepatic disease (AST or ALT ≥200 mg/dL)
Show all 19Show fewer
- Participants with renal disease (serum creatinine ≥2.0 mg/dL)
- Participants with pancreatitis or related disorders
- Participants with acute infectious diseases (i.e., pneumonia, acute enteritis, or urinary infection)
- Participants with chronic inflammatory diseases (i.e., rheumatoid arthritis, or lupus)
- Participants with overeating behavior
- Participants with history of cardiovascular diseases
- Participants with history of cancer
- Participants who are taking anti-obesity, anti-diabetic, diuretic, central-nervous system, antidepressant, antipsychotic, or steroid medications
- Pregnant or lactating women
- Participants who intake more than 30 g of alcohol daily
- Night-time or shift-work workers
- Participants with chronic malabsorption syndrome or cholestasis
- Participants with other medical conditions that would preclude subjects from participating in exercise and physical test
About this study
Official title: Effects of Alternate Day Fasting and Exercise on Body Weight, Visceral Fat, and Metabolic Parameters in Overweight or Obese Adults: A Randomized Controlled Trial
Alternate day fasting is known to be helpful to control weight and have a positive effect on insulin resistance and cardiovascular risk factors. However, there have been no studies on weight reduction program combining alternate day fasting with exercise which preserves lean mass in Korea. The purpose of this randomized clinical trial is to examine the effects of alternate day fasting and exercise on weight reduction, visceral fat, and metabolic parameters in overweight or obese adults.
- Conditions
- Overweight, Obesity, Diet Modification, Exercise
- Being tested
- Alternate Day Fasting, Exercise
- Medical subject headings
- Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternate Day FastingBehavioural
During the 8-week intervention, participants consumed 25% of their daily recommended energy intake (approximately 500 kcal) on each "fast day" (24 h), and consumed food ad libitum on each "feed day" (24 h). The "fast day" and "feed day" were repeated every other day, and the "fast day" occurred 3 days per week.
ExerciseBehavioural
During the 8-week intervention, participants visited the research center gym at least three times per week and received exercise logs. Each exercise session began with 5 minutes of warm-up and ended with 5 minutes of cool-down. Resistance training was performed using weight training machines, barbells, and dumbbells for 40 minutes. Aerobic exercise was performed on motorized treadmills for 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Alternate Day Fasting and Exercise | Experimental | Not described Receives: Behavioral: Alternate Day Fasting; Behavioral: Exercise |
| Alternate Day Fasting | Experimental | Not described Receives: Behavioral: Alternate Day Fasting |
| Exercise | Experimental | Not described Receives: Behavioral: Exercise |
| Control | No intervention | regular eating and exercise habits for 8 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
body weight (kg)
Measured: baseline, 8 weeks
Secondary outcomes (6)
Change in visceral fat
visceral fat areas (cm2) measured by fat measurement computed tomography (CT)
Measured: baseline, 8 weeks
Change in fasting glucose
fasting glucose (mg/dL)
Measured: baseline, 8 weeks
Change in insulin
insulin (mcIU/mL)
Measured: baseline, 8 weeks
Change in triglyceride
triglyceride (mg/dL)
Measured: baseline, 8 weeks
Change in high-density lipoprotein cholesterol (HDL-cholesterol)
HDL-cholesterol (mg/dL)
Measured: baseline, 8 weeks
Change in low-density lipoprotein cholesterol (LDL-cholesterol)
LDL-cholesterol (mg/dL) calculated using the Friedewald equation
Measured: baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start10 Apr 2014
- Primary completion8 Mar 2016
- Study completion8 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji-Won Lee, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03652532
- Sponsor's protocol ID
- 4-2014-0117
- Status last verified
- Aug 2018
- First submitted
- 28 Aug 2018
- Last updated
- 29 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
PubMed 33512717Oh M, Kim S, An KY, Min J, Yang HI, Lee J, Lee MK, Kim DI, Lee HS, Lee JW, Jeon JY. Effects of alternate day calorie restriction and exercise on cardio-metabolic risk factors in overweight and obese adults: an exploratory randomized controlled study. BMC Public Health. 2018 Sep 15;18(1):1124. doi: 10.1186/s12889-018-6009-1.
PubMed 30219052
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Alternate Day Fasting and Exercise on Body Weight, Visceral Fat, and Metabolic Parameters in Overweight or Obese Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03652532
- Acronym / sponsor ID
- 4-2014-0117
- Conditions
- Overweight, Obesity, Diet Modification, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 10 Apr 2014 (actual)
- Primary completion
- 8 Mar 2016 (actual)
- Study completion
- 8 Mar 2016 (actual)
- First posted
- 29 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Alternate day fasting is known to be helpful to control weight and have a positive effect on insulin resistance and cardiovascular risk factors. However, there have been no studies on weight reduction program combining alternate day fasting with exercise which preserves lean mass in Korea. The purpose of this randomized clinical trial is to examine the effects of alternate day fasting and exercise on weight reduction, visceral fat, and metabolic parameters in overweight or obese adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Alternate Day Fasting and Exercise | Experimental | Behavioral: Alternate Day Fasting, Behavioral: Exercise |
| Alternate Day Fasting | Experimental | Behavioral: Alternate Day Fasting |
| Exercise | Experimental | Behavioral: Exercise |
| Control | No intervention | –regular eating and exercise habits for 8 weeks |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 20-65 years
- Body mass index (BMI) more than 23.0 kg/m² (overweight or obese for Asian populations, according to the World Health Organization)
Key exclusion criteria (19 listed)
- Participants with weight gain more than 5kg in the last 3 months
- Participants with history of bariatric surgery
- Participants with secondary obesity, such as hypothyroidism
- Participants with uncontrolled hypertension or type 1 diabetes
- Participants who are taking anti-diabetic medications due to type 2 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alternate Day FastingDuring the 8-week intervention, participants consumed 25% of their daily recommended energy intake (approximately 500 kcal) on each "fast day" (24 h), and consumed food ad libitum on each "feed day" (24 h). The "fast day" and "feed day" were repeated every other day, and the "fast day" occurred 3 days per week. | Behavioural | Alternate Day Fasting, Alternate Day Fasting and Exercise |
| ExerciseDuring the 8-week intervention, participants visited the research center gym at least three times per week and received exercise logs. Each exercise session began with 5 minutes of warm-up and ended with 5 minutes of cool-down. Resistance training was performed using weight training machines, barbells, and dumbbells for 40 minutes. Aerobic exercise was performed on motorized treadmills for 20 minutes. | Behavioural | Alternate Day Fasting and Exercise, Exercise |
Primary outcome
Change in body weight
Time frame: baseline, 8 weeks
body weight (kg)
6 secondary outcomes
Change in visceral fat
Time frame: baseline, 8 weeks
Change in fasting glucose
Time frame: baseline, 8 weeks
Change in insulin
Time frame: baseline, 8 weeks
Change in triglyceride
Time frame: baseline, 8 weeks
Change in high-density lipoprotein cholesterol (HDL-cholesterol)
Time frame: baseline, 8 weeks
Change in low-density lipoprotein cholesterol (LDL-cholesterol)
Time frame: baseline, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Derived from this study: PubMed 33512717Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
- Derived from this study: PubMed 30219052Oh M, Kim S, An KY, Min J, Yang HI, Lee J, Lee MK, Kim DI, Lee HS, Lee JW, Jeon JY. Effects of alternate day calorie restriction and exercise on cardio-metabolic risk factors in overweight and obese adults: an exploratory randomized controlled study. BMC Public Health. 2018 Sep 15;18(1):1124. doi: 10.1186/s12889-018-6009-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Alternate Day Fasting and Exercise in people with Overweight and Obesity, run by Gangnam Severance Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: baseline, 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03652532, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.